Brielle Smith Young
New York,NY
Summary
Talented clinical research professional and experienced Senior Project Manager gifted at delivering high-quality projects while meeting tight deadlines from Start-Up to Close Out, managing the study finances to ensure profitability, mitigating risks, and working well in team-based environments. Engaging and personable to manage key milestones and deliver exemplary customer service. Highly organized and thorough with good operational planning and problem-solving abilities in order to maintain successful client relationships.
Overview
8
8
years of professional experience
Work History
Senior Project Manager/Global Project Lead
PPD, Part Of ThermoFisher
03.2023 - Current
- Vaccines (Chikungunya, Influenza, RSV)
- Acting as Associate Director PL since Feb2023.
- Continuously met expedited timelines ahead of target date
- Negotiated and recovered ~$23M of overburn costs
- Oversees Projects on a large portfolio to support cross-functional teams, report progress, and provide high-quality deliverables upholding ICH-GCP.
- Streamlined project management processes by implementing agile methodologies, resulting in improved efficiency and reduced costs across the Portfolio.
- Developed and maintained relationships with the client and third-party vendors to meet objectives and boost rapport.
- Led cross-functional teams for successful project delivery within scope, schedule, and budget constraints.
- Directed changes to project scope and cost and implemented appropriate change management processes to keep project on time.
- Verified quality of deliverables and conformance to specifications before submitting to clients.
- Provided outstanding service to clients through effective communication and prompt issue resolution to facilitate future business opportunities.
- Scheduled and facilitated meetings between project teams to discuss deliverables, schedules and conflicts.
- Mentored project managers and other team members to enhance their skills and career growth.
- Monitored project progress, identified potential risks and took corrective action as needed.
- Presented regular status reports to executive leadership, providing insights into progress made toward achieving key milestones.
Project Manager/ Global Project Lead
PPD
06.2021 - 03.2023
- Vaccines (Chikungunya, Influenza, RSV)
- Acting as Senior Project Lead since Aug 2022.
- Oversaw large portfolio of projects to support teams, report progress, and influence positive outcomes for key stakeholders.
- Developed and implemented project plans and budgets to ensure successful execution.
- Developed and maintained relationships with key stakeholders to meet objectives and boost rapport.
- Directed changes to project scope and cost and implemented appropriate change management processes to keep project on track.
- Developed and led multi-disciplinary team to redefine problems and reach solutions based on different perspectives.
- Developed and maintained project budgets to control costs and meet organizational and project goals.
- Verified quality of deliverables and conformance to specifications before submitting to clients.
- Provided outstanding service to clients through effective communication and prompt issue resolution to facilitate future business opportunities.
- Tracked project and team member performance closely to quickly intervene in mistakes or delays.
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
- Monitored project progress, identified risks and took corrective action as needed.
- Communicated project plans and progress to key stakeholders and project contributors.
- Monitored project progress, identified risks and implemented corrective measures to acquire success.
- Coordinated cross-functional teams to determine timely delivery and compliance of project requirements.
- Analyzed project performance data to identify areas of improvement.
Project Manager/Global Project Lead
Syneos Health
03.2020 - 06.2021
- Rare Disease: Neuromyelitis Optica (Pediatrics) and Paroxysmal Nocturnal Hemoglobinuria
- Responsible for globally maintaining and coordinating the logistical aspects of a rare disease Clinical Trial on a global scale to a high-quality standard and following ICH-GCP guidelines.
- Establishes the scope and budget for the study as a true reflection of customer and internal expectations. Ensure completion of month end financials
- Develops, tracks, and provides project status reports and financial reports to client and internal teams
- Oversee risk and issue management process
- Manages and communicates the project resources needs to Resourcing Team and Project Director
- Oversee Investigator payments and review/approve study expenses.
- Manage contracted vendors, contribute to the evaluation and selection of vendors, and ensure vendor contractual agreements are followed during daily operations by the project team.
- Lead global matrix teams successfully and efficiently to ensure successful completion of project deliverables
- Develop applicable project plans and study processes
- Lead internal and client meetings with clear objectives, progress of our results, and open communication to encourage teamwork and collaboration
- Present project status during monthly project review meetings to department and partnership leadership
Senior Project Specialist
Syneos Health
02.2019 - 03.2020
- Rare Disease: Neuromyelitis Optica (Pediatrics) and Paroxysmal Nocturnal Hemoglobinuria
- Provides support to the Global Project Lead with global PM tasks
- Manages risk management process with minimal support
- Lead client and internal meetings
- Main point of contact for internal team, client, and vendors
- Develops, tracks, and provides project status reports and financial reports to Project Director
- Leading Matrix teams successfully and efficiently to ensure successful completion of project deliverables
- Ensures contracted services and expectations of assigned projects are carried out by project teams in accordance with executed contracts and customers' requirements
- Manages study vendors on a global level to ensure proper vaccines, antibiotics, medical
equipment, and laboratory supplies are ordered for the sites in accordance with executed contracts and within budget. - Tracks budget expenses, grant payments, and investigator payments
- Develops study documents, study processes, and creates templates for Investigator Site File, sends site correspondence about new study updates, and provides sites with their materials for SIV
- Set-up, maintain and close out project files and study information (e.g. regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, data queries) on a variety of databases and systems
Clinical Research Coordinator
Richard H. Weisler MD, PA, And Associates
10.2018 - 02.2019
- Alzheimer’s Disease, Major Depressive Disorder, Bipolar I/II Disorder
- Carried out psychiatric clinical trials for clinical research subjects while abiding by ICH/GCP Guidelines
- Maintained Regulatory Documents (1572, Financial Disclosure Forms, Curriculum Vitae, Medical Licenses, verified members on the Delegation of Authority were properly trained by the Investigator, kept up to date Informed Consents and Protocols, etc.), Investigator Site File binders, IP and IXRS, and EDC entry/query resolution
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities, subject visits, and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Skilled at working independently and collaboratively in a team environment.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
Clinical Research Coordinator
Wake Research Associates/Carolina Phase
06.2017 - 10.2018
- Experience with multiple Phase I, Phase II-IV, and medical device studies
- Ability to quickly learn and properly execute study protocols
- Proficient in reviewing medical records to properly decipher a patient’s eligibility for a study
- Immediately identify and report an adverse/serious adverse event
- Recruited patients by successfully performing phone screens and/or reviewing medical records
- Maintained Regulatory Documents, ensured members on the Delegation of Authority were properly trained by the Investigator, maintained Investigator Site File binders, IP and IXRS, and EDC entry/query resolution
- Collected and packaged lab samples, collected ECG/EKG’s, vital signs, and administered multiple patient questionnaires
- Conducted Phase I studies and assisted managing the Phase I unit (Organized patient
medications, study visits/IVs/lab draws, and staff scheduling) - Organized sleep studies and scheduled proper subject visits and assessments per protocol
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
Clinical Research Coordinator
PMG Research of Wilmington
05.2016 - 06.2017
- Established and maintained a new satellite site within a larger health facility
- Managed 5 studies (study visits, data entry, recruitment calls, lab processing and Regulatory Binders) and 2 Investigators while being the only employee of PMG Research at the site
- Responsible for training Clinical Research Interns for 6 months
- Proficient in reviewing medical records to properly decipher a patient’s eligibility for a study and/or accurately report an adverse event/serious adverse event
- Recruited patients by performing phone screens or reviewing medical records
- Maintained Regulatory Documents, ensured members on the Delegation of Authority were properly trained by the Investigator, maintained Investigator Site File binders, IP and IXRS, and EDC entry/query resolution
- Collected and packaged lab samples, collected ECG/EKG’s, vital signs, and administered multiple patient questionnaires
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Demonstrated strong organizational and time management skills while managing multiple projects.
Clinical Research Coordinator Intern
PMG Research Of Wilmington
09.2015 - 05.2016
- With hands on experience, I was able to learn about what it takes to execute a research study. I was able to appreciate the importance and fully understand certain regulatory documents
- Trained on lab processing, vital signs, and electrocardiograms
- Gathered, processed, and shipped lab specimens.
- Determined cause of unexpected test results and other issues by identifying and resolving technical and equipment problems.
- Gathered and evaluated quality assurance data to identify issues and improve process efficiency.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Education
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
Wilmington, NC05.2016
Skills
- Team Leadership
- Financial Management and Budget Development
- Complex Problem-solving; Solution Oriented
- Systemic Thinking
- Managing Multiple Projects
- Project Goals and Milestones
- High-quality delivery
Timeline
Senior Project Manager/Global Project Lead
PPD, Part Of ThermoFisher
03.2023 - Current
Project Manager/ Global Project Lead
PPD
06.2021 - 03.2023
Project Manager/Global Project Lead
Syneos Health
03.2020 - 06.2021
Senior Project Specialist
Syneos Health
02.2019 - 03.2020
Clinical Research Coordinator
Richard H. Weisler MD, PA, And Associates
10.2018 - 02.2019
Clinical Research Coordinator
Wake Research Associates/Carolina Phase
06.2017 - 10.2018
Clinical Research Coordinator
PMG Research of Wilmington
05.2016 - 06.2017
Clinical Research Coordinator Intern
PMG Research Of Wilmington
09.2015 - 05.2016
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
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